Effectiveness and safety of Baricitinib in alopecia areata: a prospective cohort study.

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Bibliographic Details
Title: Effectiveness and safety of Baricitinib in alopecia areata: a prospective cohort study.
Authors: Muñoz-Barba D; Dermatology Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.; Dermatology Department, School of Medicine, University of Granada, Granada, Spain., García-Moronta C; Dermatology Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.; Dermatology Department, School of Medicine, University of Granada, Granada, Spain., Haselgruber-de Francisco S; Dermatology Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.; Dermatology Department, School of Medicine, University of Granada, Granada, Spain., Sánchez-Díaz M; Dermatology Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.; Dermatology Department, School of Medicine, University of Granada, Granada, Spain.; Institute of Biosanitary Research IBS, Granada, Spain., Arias-Santiago S; Dermatology Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.; Dermatology Department, School of Medicine, University of Granada, Granada, Spain.; Institute of Biosanitary Research IBS, Granada, Spain.; Trichology Clinic, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Source: The Journal of dermatological treatment [J Dermatolog Treat] 2025 Dec; Vol. 36 (1), pp. 2583877. Date of Electronic Publication: 2025 Nov 24.
Publication Type: Journal Article; Observational Study
Language: English
Journal Info: Publisher: Informa Healthcare Country of Publication: England NLM ID: 8918133 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1471-1753 (Electronic) Linking ISSN: 09546634 NLM ISO Abbreviation: J Dermatolog Treat Subsets: MEDLINE
Imprint Name(s): Publication: London : Informa Healthcare
Original Publication: Houndmills, Basingstoke, Hampshire, UK : M. Dunitz and Macmillan Press, [c1989]-
MeSH Terms: Alopecia Areata*/drug therapy , Alopecia Areata*/diagnosis , Azetidines*/adverse effects , Azetidines*/therapeutic use , Azetidines*/administration & dosage , Sulfonamides*/adverse effects , Sulfonamides*/therapeutic use , Sulfonamides*/administration & dosage , Pyrazoles*/adverse effects , Pyrazoles*/therapeutic use, Humans ; Purines/adverse effects ; Female ; Male ; Prospective Studies ; Adult ; Middle Aged ; Treatment Outcome ; Severity of Illness Index ; Young Adult ; Follow-Up Studies
Abstract: Background and Objectives: Baricitinib was effective in treating severe alopecia areata (AA) in clinical trials, yet real-world prospective data remain scarce. The aim of this study was to assess real-world effectiveness and safety of Baricitinib.
Patients and Methods: A prospective observational study was conducted including 48 adults with severe AA over a 12-month follow-up. Clinical response, laboratory data, and adverse events were assessed. Predictors of response were also explored. The primary endpoint was defined as the attainment of a Severity of Alopecia Tool (SALT) score <20%, sustained over at least two consecutive assessments separated by ≥12 weeks within the first year of therapy.
Results: A clinically meaningful response (SALT <20) was achieved by 58.3% of patients and 37.5% achieved a complete response (SALT <10). Early responders represented 29.5% of the cohort. Eyebrow and eyelash regrowth improved ( p  < 0.01). Predictors of favorable response included lower baseline SALT, shorter disease duration, and higher basal erythrocyte sedimentation rate (ESR). No serious adverse events were reported.
Conclusions: Baricitinib is effective and safe in the real-world management of severe AA, especially when initiated early in patients with lower baseline severity and elevated ESR. These findings highlight the relevance of timely intervention and appropriate patient selection.
Contributed Indexing: Keywords: Alopecia areata; Baricitinib; Janus kinase inhibitors; hair
Substance Nomenclature: ISP4442I3Y (baricitinib)
0 (Purines)
0 (Azetidines)
0 (Sulfonamides)
0 (Pyrazoles)
Entry Date(s): Date Created: 20251124 Date Completed: 20251124 Latest Revision: 20251124
Update Code: 20251124
DOI: 10.1080/09546634.2025.2583877
PMID: 41277365
Database: MEDLINE
Description
Abstract:Background and Objectives: Baricitinib was effective in treating severe alopecia areata (AA) in clinical trials, yet real-world prospective data remain scarce. The aim of this study was to assess real-world effectiveness and safety of Baricitinib.<br />Patients and Methods: A prospective observational study was conducted including 48 adults with severe AA over a 12-month follow-up. Clinical response, laboratory data, and adverse events were assessed. Predictors of response were also explored. The primary endpoint was defined as the attainment of a Severity of Alopecia Tool (SALT) score &lt;20%, sustained over at least two consecutive assessments separated by ≥12 weeks within the first year of therapy.<br />Results: A clinically meaningful response (SALT &lt;20) was achieved by 58.3% of patients and 37.5% achieved a complete response (SALT &lt;10). Early responders represented 29.5% of the cohort. Eyebrow and eyelash regrowth improved ( p  &lt; 0.01). Predictors of favorable response included lower baseline SALT, shorter disease duration, and higher basal erythrocyte sedimentation rate (ESR). No serious adverse events were reported.<br />Conclusions: Baricitinib is effective and safe in the real-world management of severe AA, especially when initiated early in patients with lower baseline severity and elevated ESR. These findings highlight the relevance of timely intervention and appropriate patient selection.
ISSN:1471-1753
DOI:10.1080/09546634.2025.2583877